Alosetron hydrochloride (Lotronex), a prescription drag manufactured by GlaxoWellcome, and used to treat irritable bowel syndrome in women, has been withdrawn after reports of serious complications.
The US Food and Drug Administration (FDA) said that it had reviewed a total of 70 cases of serious adverse events, including 49 cases of ischaemic colitis and 21 cases of severe constipation. Of the 70 cases, 34 resulted in admission to hospital without surgery, 10 resulted in surgical procedures, and three resulted in death. The administration has received two additional reports of death that it did not classify as being cases of ischaemic colitis or complications of constipation.
Alosetron, approved by the Food and Drug Administration in February 2000, had been used to treat the diarrhoea predominant form of irritable bowel syndrome. Last August, under regulations that became effective in 1999 and were designed to warn patients about side effects, alosetron became the first drag to have a treatment guide for patients.
The guide tells patients that if they become severely constipated while taking alosetron, they should stop taking the drag immediately and contact their doctors. They are told to do the same if they get bothersome constipation with increasing abdominal discomfort.
Alosetron is contraindicated in women with a history of intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation and/or adhesions; a history of ulcerative colitis; active diverticulitis; or current Crohn's disease or ulcerative colitis (or a history of such a disease).
James Palmer, GlaxoWellcome's director of medical, regulatory, and product strategy, said of the withdrawal, "We greatly regret this outcome and believe that alosetron is effective, that its side effects are manageable, and that the benefits of the product ... outweigh the risks."
The company said that about half a million prescriptions had been written for the drug.
Dr Sidney Wolfe, director of the health research group of Public Citizen, a Washington based, non-profit consumer watchdog, said that two petitions had been presented to the Food and Drug Administration by his group earlier this year asking that alosetron be taken off the market. He said that in clinical trials there had been little difference in effectiveness between alosetron and placebo in treating irritable bowel syndrome.
Dr Wolfe said, "Once again the FDA approved a drug that should not have been approved and waited far too long to withdraw it from the market."
COPYRIGHT 2000 British Medical Association
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